A Phase I,Randomized, Double Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

Bristol-Myers Squibb1 site in 1 country32 target enrollmentNovember 1995

ConditionsPsoriasis Vulgaris

DrugsAbatacept

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Psoriasis Vulgaris
Sponsor: Bristol-Myers Squibb
Enrollment: 32
Locations: 1
Primary Endpoint: Pharmacokinetics throughout study period
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this protocol is to determine the single-dose pharmacokinetics and immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion through the inclusion of placebo controls at each dose level.

Registry

clinicaltrials.gov

Start Date

November 1995

End Date

June 1996

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

•Subjects required to have a know diagnosis of psoriasis vulgaris involving 5-49% of total body surface area (BSA) for at least six months prior to randomization.
•Subjects clinically insignificant abnormal laboratory or ECG test results who were otherwise healthy and met all remaining eligibility criteria.

Exclusion Criteria

•Evidence of active bacterial or viral infections at the time of enrollment, including any history of or clinical evidence of infection with Human Immunodeficiency virus (HIV) Hepatitis B or Hepatitis C.
•Any underlying metabolic, hematologic, pulmonary, cardiac, renal hepatic, infectious, psychiatric or gastrointestional condition, which in the opinion of the investigator, placed the subject at unacceptable risk from participation in a study with potentially immunosuppresive therapy.